Overweight, Obesity
Conditions
Interventions
A:On the second day, take 2.4g (3 tablets) of Ruijian with 150ml of room temperature water and wait for 30 minutes. On the third day, take 4.8g (6 tablets) of Ruijian with 300ml of room temperature wa
B:On the second day, take 4.8g (6 tablets) of Ruijian with 300ml of room temperature water and wait for 30 minutes. On the third day, take 2.4g (3 tablets) of Ruijian with 150ml of room temperature wa
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Males aged =18 and =65 years old at the time of signing the informed consent form; 2. BMI =24 kg/m2, and weight >50kg; (According to the expert consensus on weight management process for overweight or obese population (2021), overweight is defined as BMI =24.0 and < 28 kg/m2; obesity is defined as BMI =28kg/m2) 3. Willing to communicate with researchers, able to understand and follow the trial requirements, voluntarily participate in the trial, understand and sign the written ICF, and willing and able to comply with the visit schedule, medication plan, laboratory tests and other clinical trial procedures.
Exclusion criteria
Exclusion criteria: 1. Known to be allergic to Ruijian or any of its components or related formulations; 2. Subjects with allergic diseases or allergic constitution; 3. Subjects with severe diseases of the central nervous system, cardiovascular system, respiratory system, urinary system, blood system, metabolic disorders, etc., which are deemed unsuitable for participation in the clinical trial by the researcher; 4. Subjects with any digestive system diseases, including but not limited to chronic diarrhea, gastric paresis, gastroesophageal reflux disease, Crohn's disease, ulcerative colitis, pancreatitis, gastrointestinal perforation, severe intestinal obstruction, etc.; 5. Subjects with diseases that may affect gastric emptying (migraine, diabetes, hypothyroidism, scleroderma, etc.); 6. Subjects with a history of gastric bypass surgery or other gastrointestinal surgery; 7. Subjects with a history of eating disorders, including but not limited to anorexia nervosa, bulimia, etc.; 8. Subjects who have had acute diarrhea or constipation within 2 weeks before screening; 9. Subjects who have had acute upper respiratory tract infection within 2 weeks before screening; 10. Subjects who have taken any drugs that may affect gastric emptying within 2 weeks before screening (H2 receptor antagonists, proton pump inhibitors, gastric mucosal protectants, anticholinergic inhibitors, calcium channel inhibitors, non-steroidal anti-inflammatory drugs, laxatives, antidiarrheal drugs, traditional Chinese medicine and/or proprietary Chinese medicine that regulate gastric function, etc.); 11. Subjects who have received blood transfusion or used blood products or lost blood =400 mL for other reasons within 3 months before screening; 12. Subjects who have participated in other drug clinical trials and used trial drugs within 3 months before screening; 13. Subjects who smoked more than 5 cigarettes per day within 1 year before screening; 14. Subjects who were alcohol addicts within 1 year before screening, current or past heavy drinkers (drinking more than 14 standard units per week, 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of liquor with 40% alcohol or 150 mL of wine), or those who tested positive in alcohol breath test; 15. Subjects who were drug users within 1 year before screening, or those who tested positive in drug screening; 16. Subjects who cannot quit smoking or drinking during the trial; 17. Subjects who tested positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), treponema pallidum particle agglutination assay (TPPA) or acquired immunodeficiency syndrome (HIV) antibody; 18. Subjects with abnormal and clinically significant chest X-ray results; 19. Subjects whose total bilirubin (TBIL) > upper limit of normal (ULN) at screening or baseline; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times ULN; 20. Subjects whose estimated glomerular filtration rate (eGFR) 450 ms, and/or other clinically significant abnormalities; 22. Subjects with abnormal vital signs at screening or baseline: ear temperature > 37.5?, pulse rate > 100 beats/min or < 50 beats/min, systolic blood pressure = 140mmHg or < 90mmHg, diastolic blood pressure = 90mmHg or < 50mmHg; 23. Subjects who plan to have children within 3 months; 24. Subjects who cannot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in gastric half-emptying time (Gastric Emptying, GE t1/2) under various administration methods.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in blood glucose, insulin, and GLP-1 at various time points (30 min, 60 min, 120 min, 180 min, 240 min) after a radioactive detection meal.;The incidence and severity of adverse events, clinically significant abnormal physical examination findings, vital signs, and laboratory test results.; | — |
Countries
China
Contacts
Public ContactZhang Jing, Guan Yihui
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed